FDA product code SEZ: Radiological Software Device To Predict Future Breast Cancer Risk

SEZ is the FDA product code for radiological software device to predict future breast cancer risk. It is a Class II device, regulated under 21 CFR 892.8500 and reviewed by the Radiology panel. Devices under SEZ reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

Definition

A radiological software device to predict future breast cancer risk is a device that analyzes radiological images generated by breast imaging modalities and/or inputs derived from radiological images to provide qualified healthcare professionals with a prediction of the risk of future (incident) breast cancer. This device produces a numeric probability and/or risk category indicative of the patient’s future breast cancer risk from the time the analyzed images were acquired. This device is not intended to diagnose, detect, or inform the treatment of cancer. The output of this device is not intended to guide interpretation of imaging exams.

Classification

Recalls for SEZ devices

openFDA lists no recalls for product code SEZ.

Frequently asked questions

What is FDA product code SEZ?

SEZ is the FDA product code for radiological software device to predict future breast cancer risk. It is a Class II device, regulated under 21 CFR 892.8500 and reviewed by the Radiology panel.

What device class is SEZ?

Class II, regulation 21 CFR 892.8500. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code SEZ
• Run a recall and safety report across every SEZ manufacturer
• Watch product code SEZ for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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